Organizational changes at the FDA’s Office of Combination Products (OCP) are expected to slow the issuance of guidance documents and regulations for combination products, according to an industry consultant.
“There’s almost a completely new staff. … They are going to be on a steep learning curve, and unfortunately progress is going to be slow for a while, again,” Michael Gross, a principal of Chimera Consulting, said at the recent Pharma MedDevice conference in Philadelphia.
One important loss was attorney Jim Cohen, who worked on a proposed rule for good manufacturing practices (GMP) for combination products. OCP also has a new director, Thinh Nguyen, who succeeded Mark Kramer, the office’s director since 2001.
Promulgation of the rule is important because there is no legally binding document that lists exactly what companies will need to comply with in terms of the drug GMP and device quality systems regulations, Gross said. There is a draft guidance available, but it is nearly four years old.Despite the personnel losses at OCP, Gross still expects the FDA to release the GMP rule this year — just not in the spring when it was expected.